This trial is active, not recruiting.

Condition testicular germ cell tumor
Treatments immunohistochemistry staining method, laboratory biomarker analysis, radionuclide imaging
Sponsor Eastern Cooperative Oncology Group
Collaborator National Cancer Institute (NCI)
Start date May 1999
End date December 2004
Trial size 76 participants
Trial identifier NCT00003800, CDR0000066944, ECOG-8897, U10CA021115


RATIONALE: Diagnostic procedures may improve a doctor's ability to predict the recurrence of testicular cancer.

PURPOSE: Diagnostic trial to detect the risk of recurrent disease in patients who have stage I testicular cancer and who have undergone orchiectomy within the previous 12 weeks.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
(No Intervention)
Observation following orchiectomy
immunohistochemistry staining method
laboratory biomarker analysis
radionuclide imaging

Primary Outcomes

Evidence of regional or metastatic spread
time frame: observed at least annually

Eligibility Criteria

Male participants at least 15 years old.

DISEASE CHARACTERISTICS: - Clinical stage I nonseminomatous germ cell tumor of the testis - Must have had a radical inguinal orchiectomy with or without retroperitoneal lymph node dissection within prior 12 weeks - AFP and HCG normal or decreasing after orchiectomy at a rate consistent with known half lives - Pathology blocks and radiologic studies available - No metastatic disease on physical exam or chest or abdominal/pelvic CT - No pure seminoma (unless associated with elevated AFP at diagnosis) PATIENT CHARACTERISTICS: Age: - 15 and over Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No prior malignancy including prior primary testicular cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics

Additional Information

Official title Correlation of Histopathology, Immunohistochemistry and Quantitative Radiology With Outcome in Early Stage Nonseminomatous Germ Cell Tumor
Description OBJECTIVES: - Use histopathological and immunohistological analysis of the primary testis tumor along with quantitative radiographic assessment to identify a subset of patients with clinical stage I nonseminomatous germ cell tumor of the testis who have a very low risk of metastasis. - Compare these findings with other predictive models of risk of metastasis after orchiectomy in this group of patients. OUTLINE: Patients undergo primary retroperitoneal lymph node dissection (RPLND) or active surveillance as management of their disease. The choice of treatment is determined by the physician and the patient. Patients with pathologically positive resected lymph nodes may undergo treatment (observation or adjuvant chemotherapy) at investigator's discretion. All patients are tested by quantitative radiology and blood markers (HCG and AFP) at baseline and then at various times after surgery to identify pathologic stage II disease. The timing of these studies depends on the stage of disease and/or type of disease management. Patients who undergo RPLND, have stage I or II disease, and do not receive adjuvant therapy (radiation or chemotherapy) are followed monthly during year 1, every 2 months during year 2, every 6 months during years 3-5, and annually thereafter. Patients who undergo RPLND, have stage II disease, and receive adjuvant therapy are followed every 2 months during year 1, every 4 months during year 2, every 6 months during years 3-5, and annually thereafter. Patients who do not undergo RPLND are followed monthly during year 1, every other month during year 2, every 6 months during years 3-5, and annually thereafter. PROJECTED ACCRUAL: A total of 315 patients will be accrued for this study within 3 years.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Eastern Cooperative Oncology Group.